Prescription drugs for women: How safe? How effective? How necessary?

Introduction

When we fill a prescription at the pharmacy, how assured can we be that the drug we are about to take is going to be both safe and effective? Or that it is actually necessary? How is it that women make up only 51% of the population but consume 63% of the drugs? Does this mean women actually need more drugs than men, or are women being overmedicated? Here we examine critically, with a sex- and gender-based analysis (SGBA)*, these and other questions related to women and prescription drug use.

We think it is crucial to look at women and prescription drug using a gender lens It can help us better understand why women, especially marginalized women such as elderly, poor and Aboriginal women, are prescribed anti-anxiety and sleeping pills at a much higher rate than are men. And it is because of women’s health advocates pushing for SGBA in clinical trials that new drugs used on women are now being actually tested on women. While women and men react differently to the same drugs, until recent years, many drugs were tested only on men. Consequently, it was not known how safe or effective drugs were for women.

In this special resource section, we first look at women and prescription drug use in general, asking such questions as: Why do we see overprescribing to women, and why are women’s lives becoming “medicalized” so that natural stages such as menopause or menstruation are now seen as drug-treatable conditions? Next, we cast a critical eye on how drugs are tested, regulated, promoted, and monitored for adverse and side effects, and how each of these processes affects women’s health. We also provide, as illustrations, stories about the safety and/or effectiveness of particular drugs, and the health protection lessons we’ve learned from them. Finally, we provide a selection of searchable databases with information on specific drugs and drug trials, both from Canada and throughout the world.

How do we look at women’s drug use through a gender lens?

Why are so many more women than men prescribed drugs? Does the new practice of “chemoprevention” (using drugs to prevent disease) affect women more than men? Why are many natural processes of women’s bodies, such as menstruation and menopause, now seen as conditions requiring drug treatment? Here you will find resources that examine these questions.

The Push to Prescribe: Women & Canadian Drug PolicyEdited by Anne Rochon Ford and Diane Saibil, Women’s Press, 2010A book by Women and Health Protection that delves into the world of prescription drugs in Canada, and considers the impact on the health of women. From the inadequate testing of many drugs on women in clinical trials, to the sometimes questionable portrayal of women in illegal prescription drug advertising, Canadian drug policy has not always paid attention to how women and men are affected differently.

More than Meets the Eye: Women and Direct‑to‑Consumer AdvertizingBy Jennifer Bernier, Barbara Clow, Jean Steinberg and Anne Rochon Ford, in Rising to the Challenge:Sex‑ and gender‑based analysis for health planning, policy and research in Canada, pp. 152-155, Atlantic Centre of Excellence for Women’s Health, 2009Argues that, while few studies have yet examined the effects of DTCA on our health, DTCA tends to exploit as well as to perpetuate gender role stereotypes.

Remembering Ruth CooperstockWomen and Pharmaceuticals: Twenty Years Later, A symposium co-sponsored by the Ruth Cooperstock Memorial Lectureship Committee and Women and Health Protection, 2005Presents a helpful introduction to the issues surrounding women and prescription drugs, by offering a historical perspective, an evaluation of the present when women are being overprescribed drugs, and finally, what a positive vision for the future might look like, when “women’s lives are not medicalized” and “social and political solutions, rather than technical or pharmaceutical fixes, are the norm.”

Safety and the Precautionary PrincipleCentres of Excellence for Women’s Health Research Bulletin, Volume 3, Number 2, Spring 2003Features the contributions of Women and Health Protection, a group of researchers, health providers, educators, and consumers interested in policy-directed research and public education on health protection issues. Covers a wide array of topics relating to women and drug safety.

Factors Associated with Women's Medication UseBy Jennifer Payne, Ineke Neutel, Robert Cho and Marie DesMeules, from: Women's Health Surveillance Report, Canadian Institute for Health Information, 2003Discusses why a significantly higher proportion of women than men in Canada are medicated. Examines the extent that social roles and other risk factors are associated with women’s higher prescription and over-the-counter drug use.

Are drugs tested appropriately for women?

Until recently, clinical trials on drugs tended to exclude women or did not distinguish between men and women in their results. Because of this, many drugs have been prescribed to women without an understanding of how women would respond to those drugs. This section offers arguments that sex must be accounted for in clinical trials, and further, that gender – the socially constructed roles of men and women at different stages of their lives – is even more pertinent to trial results.

Tri-Council Policy Statement: Ethical Conduct for Research Involving HumansChapter 4 – Fairness and Equity in Research Participation, Panel on Research Ethics, Government of Canada, December 2010Describes the ways in which women should not be excluded by research studies, as they have traditionally been, on the basis of gender, sex, reproductive capacity, or because they are pregnant or breastfeeding “unless there is a valid reason for doing so”.

Making Sense of Medical Research StudiesCanadian Women’s Health Network, 2007Addresses, in an FAQ format, the basic questions on how to read, understand and evaluate medical research reports using a gender lens.

Understanding Clinical TrialsClinicalTrials.gov, U.S. National Institute of Health, 2007Provides for those interested in participating in clinical trials, as well as anyone wanting to learn how they are conducted, a good, plain language overview of the clinical trial process and the different kinds of trials.

Participation of Women in Clinical Trials of Drug Therapies: A Context for the ControversiesBy Marianne N. Prout, MD, MPH, Susan S. Fish, PharmD, MPH, Medscape General Medicine, 2001, Volume 3, Number 4Introduces the issue of women’s exclusion from clinical drug trials, from an American perspective. Examines how and why women have historically been under-represented in or excluded from drug trials, and the negative effects this has had on women’s health care. Also questions whether women have yet achieved adequate access to clinical research.

How does the government approve and regulate our drugs? Does this process work for women?

How drugs are regulated and approved in Canada has a substantial – and sometimes negative – impact on women’s health. This section includes resources that detail this regulatory process, as well as resources that critically examine how it could be improved.

Transparency and the Drug Approval Process at Health CanadaBy Ann Silversides, Women and Health Protection, 2005Maintains that the drug regulation process in Canada is shrouded in unnecessary secrecy. Argues that the public does not have access to the full results of clinical trials submitted to approve drugs. Discusses why this lack of transparency potentially endangers the health of Canadians, especially women, and how the regulatory system should be changed to better protect us. NOTE: An updated version of this paper appears in “The Push to Prescribe” which is listed in How do we look at women’s drug use through a gender lens?

Drug regulatory failure in Canada: The Case of Diane-35By Barbara Mintzes, Women and Health Protection, 2004 Uses the example of Diane-35, a drug approved to treat women with severe acne, to discuss the lack of transparency and accountability within Health Canada’s drug regulatory processes. Explains that, despite serious concerns about Diane-35’s safety and effectiveness for its approved use, the drug continues to be prescribed to women and girls in Canada, not only for severe acne, but for off-label use for mild acne as well as for birth control.

How does drug advertising to the public and to doctors affect our drug use, and our health?

While Canada’s laws forbid direct-to-consumer advertising (DTCA) of prescription drugs, we see it happening more and more, as drug companies find legal loopholes. A significant proportion of the ads are aimed at women. Doctors who treat women are targeted with similar advertising. This section explains the laws regulating drug advertising, and examines the effects that DTCA – instead of solid, unbiased information – has on how we use drugs, and on our health.

Myth: Direct-to-Consumer Advertising is Educational for PatientsCanadian Health Services Research Foundation, 2007Debunks the idea promoted by drug companies that direct-to-consumer advertising of prescription drugs has health benefits for patients. Discusses the risks for patients being prescribed unnecessary drugs, and the astronomical costs that legalizing DTCA in Canada could entail.

What are the Public Health Implications? Direct-to-Consumer Advertising of Prescription Drugs in CanadaBy Barbara Mintzes, Centre for Health Services and Policy Research, University of British Columbia, 2006Clearly presents the public health arguments against direct-to-consumer advertising of prescription drugs (DTCA) in Canada. Concludes with several recommendations for Health Canada, including independent publicly financed information and education on drugs and better enforcement of existing legislation governing DTCA.

Information, Not Advertising: Women Want Reliable Drug Information, Not Drug AdvertisementsBy Ellen Reynolds, with background from Barbara Mintzes, Network, Fall 2005, Volume 8, Number 1/2Describes the risks for women’s health posed by direct-to-consumer advertising (DTCA) of prescription drugs in Canada. Notes that, while DTCA has been banned in Canada as in most industrialized countries, the re-interpretation of the law here has meant we are seeing DTCA passing through the loopholes, and most of the ads are aimed at women.

Once a drug is approved, who monitors its safety?

Once a drug is approved and goes on the market, it is vitally important to monitor how it performs, including its adverse reactions and side effects. Women have long been advocating for stronger monitoring systems because women are more frequent users of drugs, as well as more often the caregivers who administer drugs. This section looks at the need for women to be involved in drug monitoring, and at the monitoring system set up by Health Canada in 2009, called MedEffect.

MedEffect CanadaHealth CanadaThe website of MedEffect, launched in 2009, Health Canada’s initiative to make it easier for consumers, patients, and health professionals to report adverse reactions and side effects, obtain new safety information on drugs and other health products, and learn and better understand the importance of reporting side effects.

Is this drug safe and effective? Is it even necessary? Some case studies…

The history of prescription drugs contains many cautionary tales for women of which hormone replacement therapy, Depo Provera, and the HPV vaccine (Gardasil) are just a few examples. In this section are some of these stories. You will also find recurring tales of women being overprescribed drugs, such as anti-anxiety and sleeping pills. Finally, you will find the story of the Emergency Contraception Pill—a different kind of story, where women had to advocate strongly for full access to a much needed drug.

Stopping Depo-Provera: Why and what to do about adverse experiencesSociety for Menstrual Cycle Research, 2013Interview with Jerilynn Prior, clinician-scientist and endocrinologist, on Depo-Provera (also called “the shot,” or Depo), the four-times-a-year contraceptive injection. She explains how Depo works to prevent pregnancy, its common side effects and why and what to do about adverse experiences when stopping it.

Webinar: Anti-depressants in Pregnancy: Is There Evidence of Benefit?Presented by Dr. Barbara Mintzes, Assistant Professor, UBC Department of Pharmacology & Therapeutics, UBC Centre for Health Services & Policy Research, and Steering Committee member, Women and Health Protection, recorded October 21, 2009Presents the results of a systematic evaluation of all available studies comparing women with depression who did or did not take antidepressants during pregnancy. The researchers' goal was to find an answer to the controversial and urgent clinical question: do pregnant women benefit from taking antidepressants?

Evidence for Caution: Women and Statin UseBy Harriet Rosenberg and Danielle Allard, Women and Health Protection, 2007Examines the troubling issue of statins, one of the most common drugs prescribed to women for the prevention of heart disease. Discusses the fact that most of the clinical trials to assess their benefits and safety have focused on men. Shows that for women who have no history of heart disease, there is no substantial clinical trial evidence that statins reduce the number of heart events or deaths in women of any age.

Reflections on Depo Provera: Contributions to Improving Drug Regulation in CanadaBy Laura Shea, Women and Health Protection, 2007Tells the ongoing story of the injectable hormonal contraceptive Depo Provera. Details how, after repeated rejections, Depo Provera was approved for contraceptive use in Canada in April 1997, despite the safety concerns of women’s health groups and community organizations. This story is both important and instructive in that it shines a light on many of the problems with drug regulatory processes in Canada.

Human Papillomavirus, Vaccines and Women's Health: Questions and CautionsBy Abby Lippman, PhD, Ryan Melnychuk, PhD, Carolyn Shimmin, BJ and Madeline Boscoe, RN DU, Canadian Medical Association Journal (CMAJ), August 28, 2007; 177 (5)Details numerous safety concerns with the Gardsail vaccination, which is currently offered for free to young girls in Canada, mostly between the ages of 9-12. Gardasil is a vaccine for some forms of the human papillomavirus (HPV) which can cause cervical cancer. Summarizes some of the major questions and concerns that the authors felt needed to be addressed before there was a full-scale roll-out of an HPV vaccination program.

The Marketization of Depression: Prescribing SSRI Antidepressants to WomenBy Janet Currie, Women and Health Protection, 2005Shows that twice as many psychotropic drugs (drugs that affect the mind) are prescribed for women as for men, and this holds true for the selective serotonin reuptake inhibitor (SSRI) antidepressants. Asks why aren’t proven non-drug alternatives that address the emotional distress of women, such as exercise, support, psychotherapy, and nutritional improvements, being supported, funded and prioritized by government?

Manufacturing Addiction: The Over-Prescription of Benzodiazepines and Sleeping Pills to Women in CanadaBy Janet C. Currie, British Columbia Centre for Excellence in Women’s Health, 2003Looks at the serious problem of over-prescribing benzodiazepines (commonly known as tranquilizers) to women. Benzodiazepines are highly addictive and have profound effects on the brain and body at therapeutic doses and if taken for more than several weeks. Longer-term prescribing, particularly to women, is common. Over-prescribing of this drug is especially common among elderly women and Aboriginal women.

Hormone Therapy: Health Protection Lessons from the Women’s Health InitiativeBy Sharon Batt, Centres of Excellence for Women’s Health Research Bulletin, Spring 2003, Volume 3, Number 2Argues that Canada’s current health policies nourish the rapid development and dissemination of preventive drugs, but provide few checks on their over-promotion. Discusses how the results of the Women’s Health Initiative (WHI) challenge these biased health policies. The experience of hormone therapy is a cautionary tale to Canadians engaged in the renewal of health protection policies and our health care system. NOTE: While the WHI trial on hormone therapy was halted in 2002, analyses of that trial are still being carried out, resulting in new findings. For more information, see this website.

Where can we search for reliable information about specific drugs or treatments?

This section offers a selection of searchable databases with information on specific drugs.

Therapeutics Initiative: Evidence-Based Drug TherapyUniversity of British Columbia An initiative that provides physicians and pharmacists with up-to-date, evidence-based, practical information on prescription drug therapy. An independent organization, separate from government, the pharmaceutical industry and other vested interest groups.

MedEffect CanadaHealth CanadaHealth Canada’s initiative to make it easier for consumers, patients, and health professionals to report adverse reactions and side effects, obtain new safety information on drugs and other health products, and learn and better understand the importance of reporting side effects.

The following are all American or international sites: a note to non-American users that sometimes the brand names will not be the same as those in your home country. It’s always best to search by the generic name if you know it.

FDA Index to Drug-Specific InformationA readable website operated by the U.S. Food and Drug Administration, regulators of drugs in the United States. Contains only information about drugs for which some kind of warning has been issued – but this is a staggeringly high number of drugs.

Drugs.comClaims to “provide free, peer-reviewed, accurate and independent advice on more than 24,000 prescription drugs, over-the-counter medicines & natural products.” Funded by the Drugsite Trust, “a privately held Trust administered by two New Zealand Pharmacists.” Includes a useful “pill identification” function on the site. Displays ad banners.

The Medical LetterProvides useful drug information, but is somewhat limited in what is available for free. The information is comprehensive and thorough, but the language is geared more to health care practitioners than to the lay public.

Worst Pills, Best PillsOperated by Public Citizen out of Washington DC and a very good site but provides only a limited amount of information on each drug unless you are a subscriber. They also produce a book which is updated periodically. Includes free fact sheets on the site with such topics as “Ten Rules for Safer Drug Use.”

ErowidDeals only with psychoactive agents, including pharmaceuticals. A “member-supported organization providing access to reliable, non-judgmental information about psychoactive plants, chemicals, and related issues.” Also has a “pill identifier” function.